Circumferential Numbering System for Catheters

ABSTRACT

The disclosure relates to a system of circumferentially (preferably helically) arranging indicia on the elongate body of a medical device such as a catheter. The disclosure also relates to an anchor drain for securing a surgical drain to a fluid collection device. The anchor drain resists disconnection of the surgical drain from the fluid collection device and also resists occlusion of the conduit connecting the surgical drain and the fluid collection device, even when a suture is tied about a portion of the anchor drain inserted within the surgical drain, and resists unintentional withdrawal of the surgical drain from the body or a body cavity.

CROSS-REFERENCES TO RELATED APPLICATIONS

This application is is entitled to priority to U.S. provisional patentapplication No. 62/108,123 filed 27 Jan. 2015.

BACKGROUND OF THE DISCLOSURE

The invention relates generally to the field of medical apparatus.

BRIEF SUMMARY OF THE DISCLOSURE

The disclosure relates to an improvement in an elongate medical device(e.g., a catheter) that is insertable into the body of a patient. Theimprovement includes a plurality of indicia (e.g., numerals, letters, orother symbols) borne by the device, each of the indicia representing adistance from the indicium to the distal end of the device. The indiciacan, for example, be distributed circumferentially or helically aboutthe long axis of the device. The indicia can be present in pairs (e.g.,on opposite sides of the device), each indicium of a pair disposedequidistantly from the distal end of the device.

The disclosure also relates to an anchor drain for connecting a surgicaldrain having an outlet lumen to a fluid collection apparatus. The anchordrain has a body which includes a connection lug that is insertablewithin the outlet lumen of the surgical drain. The connection lug has aconduit extending therethrough to connect the outlet lumen of thesurgical drain to an outlet defined by the body for connecting the bodywith the fluid collection apparatus. The connection lug also has aprofiled outer surface (e.g., with one or more bulges or protrusions,such as a raised annular portion that surrounds the conduit at the endof the lug distal to the body) that resists disconnection of thesurgical drain from the anchor drain. The connection lug preferablyexhibits sufficient rigidity that it resists occlusion of the conduitwhen a suture is tied about a portion of the surgical drain into whichthe connection lug is inserted. In one embodiment, the anchor drain alsoincludes a flange that bears a hole to facilitate suturing of the anchordrain to a surface of a patient bearing the surgical drain.

BRIEF SUMMARY OF THE SEVERAL VIEWS OF THE DRAWINGS

FIG. 1 is an elevation of a catheter bearing the circumferentialnumbering system described herein.

FIG. 2 is a cross section of the catheter illustrated in FIG. 1.

FIG. 3 is a partial axonometric of the catheter illustrated in FIG. 1.

FIG. 4 consists of FIGS. 4A and 4B and illustrates aspects of the anchordrain described herein. FIG. 4A is a plan and elevation of the anchordrain, not yet connected to tubing exiting a patient's body.

FIG. 5 consists of FIGS. 5A, SB, and SC and illustrates aspects of anembodiment of the anchor drain described herein. FIG. 5A is a plan viewof the anchor drain not yet connected to tubing exiting a patient'sbody. FIG. 5B is a plan view of the anchor drain connected to tubingexiting a patient's body. FIG. 5C is an elevation of the anchor drain.

FIG. 6 consists of FIGS. 6A, 6B, and 6C and illustrates aspects ofanother embodiment of the anchor drain described herein. FIG. 6A is aplan view of the anchor drain not yet connected to tubing exiting apatient's body. FIG. 6B is a plan view of the anchor drain connected totubing exiting a patient's body. FIG. 6C is an elevation of the anchordrain.

DETAILED DESCRIPTION

The disclosure relates to two distinct technologies, namely cathetersbearing a helically-arranged, circumferential numbering system and ananchor drain for facilitating draining of fluid from a patient's body.

PART I—CIRCUMFERENTIAL NUMBERING SYSTEM FOR CATHETERS

This invention relates to the field of drains and catheters. For thepurpose of this provisional patent application the invention isillustrated using ventricular catheters. More specifically, theinvention offers an improvement to existing marking and measuringsystems on the surface of the ventricular catheters and/or other long,narrow (i.e., elongate), minimally invasive medical devices which areinserted into the body via a small port.

Indicia on the surface of the catheter indicate the distance to the tipof the probe (i.e., the distal end, which is typically inserted firstinto the patient), measuring depth of catheter/probe within the body(brain).

The traditional method of indicating distance on a catheter is toinclude numerals or other indicia along the surface of the catheter, ina straight line, parallel to the shaft. Marks can be spaced regularly(i.e. every centimeter) or some sections can have more or fewer markingsthan others (i.e. every 5 centimeters or mostly every centimeter).

Additionally, some but not all catheters have markings with acorresponding number (i.e. marking what centimeter distance from thetip); these indicia and numerals have always been printed in a lineararrangement down the surface of the catheter at a substantiallyinvariant circumferential position.

The surface material of a catheter is apt to rotate as it is advancedand/or secured. Traditional numerical systems are often difficult forthe practitioner to see the indicia, requiring the practitioner topurposefully rotate and/or withdraw the catheter to find the next numberor symbol, indicating depth. These maneuvers can compromise the locationof the catheter, cause delays, and frustrate the practitioner, resultingin health and safety issues such as misplaced catheters and infection.

The present invention seeks to provide an improvement to the markingsystem of catheters, proposing a novel method of marking the indicia oncatheters. Every marker is indicated firstly by a line circumscribingthe shaft. This will occur at, for example, 4 cm, 5 cm, 6 cm, 7 cm, 8cm, 9 cm and 10 cm from the tip of the shaft.

Each number (i.e. 4-10 cm) is printed preferably at least twice at eachlevel, and this invention proposes that each adjacent mark arerotationally offset from one another about the circumference for exampleby 180 degress (but could be another value such as 30, 60 or 90degrees), rotated about the central axis of the shaft at each interval(i.e. cm) down the length of the catheter.

By rotating the numerals themselves in a double helical pattern aroundthe surface of the catheter, the amount of probe within the body issimply and clearly legible regardless of how the catheter twists,without disturbing the placed catheter.

This indicia system could be used for plain ventricular catheters,antibiotic impregnated ventricular catheters, and/or any catheter ordrain where a legible distance from an insertion point is required.

PART II—ANCHOR DRAIN

This invention relates to the field of post-operative or wound drainsystems. More specifically, the invention offers an anchoring system tothe skin which replaces current drainage systems that have no inherentanchor to the skin, resulting frequently in the premature andunintentional disconnection and/or removal of said drains.

There are many wound and post-surgical drainage devices. Most of theseare temporarily and loosely secured to the body with tape (adhesive) andor suture. However, these methods of attachment are inadequate forpreventing accidental disconnection and/or removal during wound dressingchanges, during patient transfers, during early mobilization andphysical therapy, during bathing and even sleeping.

A traditional drain consists of two elements—the first is a hollow tubewith multiple openings at the proximal end, placed in the part or cavityof the body requiring drainage, interior to the body cavity which isthen tunneled away from the incision line and exiting out through theskin, and then cut in preparation to connect to the second component;the second component loosely connects to the distal end of the firstcomponent (outside of the body) and ultimately is attached to acollecting apparatus that drains the cavity by either suction orgravity, per the recommendation of the treating physician.

Near where the first component exits the body, at the skin, currentstrategies for securing the drain system to the patient consist ofplacing adhesive tape around the drain to the patient's skin or placinga suture through the skin and tying it around the drain (either one tieor multiple ties at various locations along the drain, and with thedrain tubing either in a straight line or in a spiral pattern) toincrease the fixity and pullout strength of the system. This techniquehas severe limitations, mainly that if the suture is adequate to preventpullout and provide stability of the system, it will occlude the lumenthereby rendering useless the drain. Tying the suture to avoid occludingthe lumen results in an ineffectual (too loose) connection to the drain.Tape and other adhesives are even less effective than suturing becauseskin movement and/or moisture causes the adhesive to fatigue and fail.

Current techniques that provide adequate drainage do not providesufficient security of the drain to the body, which can result inpremature removal or dislocation of the drain. When this occurs, fluidthat was meant to be removed will accumulate in that body cavity,leading to a myriad of complications including: infection, pain,emergent replacement (in the case of an externalized ventricular drain)or elective replacement, poor wound healing, and/or a prolonged hospitalstay.

The present invention seeks to provide an adequate anchoring systemwithout compromising the efficacy of the drainage system.

The present invention consists of a novel second component with anintegral connecting and anchoring unit to connect to the distal end ofthe first component. The first component of the drainage system remainsthe same (a hollow tube with drainage holes at the proximal end, placedwithin the body and exiting through the skin). The novelty of thissystem is in the proximal end of the second component. The secondcomponent will now consist of a male end with an integral, machined, MRIcompatible, metal (or hard plastic) conduit which resists disconnectionfrom attached tubing (e.g., cannot be disconnected from its tubingeasily or at all), and resists occlusion (e.g., cannot be occluded by asuture tied with ordinary human strength) when suturing the tubing tothe skin. The male end (proximal portion of the second component) isinserted into the female end (distal portion of the first component).The female end of the first component is cut at or near the exit pointthrough the skin. The male end inserts into the female end at or nearthe skin edge and a suture is used to not only firmly connect the two(male and female) components so they do not uncouple, but also tostrongly anchor the drainage tubing to the skin.

A single suture is all that is required to connect the male and femalecomponents of the drainage system and at the same time securely anchorthe system to the patient's skin without compromising the lumen of thedrainage system. The male component is a fixed length and can beconnected to a suction device such as a hemovac or bulb suction at thefactory or it can be assembled in the field. In the case of aventricular catheter the distal end of the male component can have thedrainage tubing connector attached at the factory or assembled in thefield. The first component (proximal end in the body cavity requiringdrainage) will have indicia markings and will require cutting at thepoint where the catheter exits the skin creating the female end andallowing coupling of the male and female components at or near the exitsite through the skin.

The connection between the first and second components would be quickly,safely and easily secured by placing the male end of the novel anchorinto the female end of the first component of the drain—at or very nearthe exit site at the skin. Because of the extreme rigidity of the malecomponent, once the female end of the tubing is placed over it, a suturecan be tied around the entire system, guaranteeing two things: asubstantially stronger system than currently exists in terms ofdisconnection and pull-out strength, and in ensuring a patent lumen.

Improvements of this BASIC ANCHOR DRAIN include the addition of flangeson or near the male end of the second component, with integral holes,allowing for multiple attachment sites with sutures, further augmentingthe pullout strength of the drainage system from the body. There wouldbe an array of sizes of the male end to accommodate the diameters ofdifferent drains/lumens.

A skilled artisan in this field appreciates the materials from which thedevices described herein can be made, as well as methods of making suchdevices.

EXAMPLES

The subject matter of this disclosure is now described with reference tothe following Examples. These Examples are provided for the purpose ofillustration only, and the subject matter is not limited to theseExamples, but rather encompasses all variations which are evident as aresult of the teaching provided herein.

Examples of the catheter numbering system are illustrated in FIGS. 1-3.

Examples of the anchor drain are illustrated in FIGS. 4-6.

The disclosure of every patent, patent application, and publicationcited herein is hereby incorporated herein by reference in its entirety.

While this subject matter has been disclosed with reference to specificembodiments, it is apparent that other embodiments and variations can bedevised by others skilled in the art without departing from the truespirit and scope of the subject matter described herein. The appendedclaims include all such embodiments and equivalent variations.

1. In an elongate medical device that is insertable into the body of a patient, the improvement comprising a plurality of indicia borne by the device, each of the indicia representing a distance from the indicium to the distal end of the device.
 2. The improvement of claim 1, wherein the indicia are distributed circumferentially about the long axis of the device.
 3. The improvement of claim 1, wherein the indicia are distributed helically about the long axis of the device.
 4. The improvement of claim 1, comprising pairs of indicia borne by the device, each of the indicia representing a distance from the indicium to the distal end of the device, each of the pairs being disposed equidistantly from the distal end of the device.
 5. The improvement of claim 4, wherein the pairs of indicia are distributed helically about the long axis of the device.
 6. The improvement of claim 1, wherein, wherein the elongate medical device is a catheter.
 7. The improvement of claim 1, wherein, wherein the elongate medical device is a ventricular catheter.
 8. The improvement of claim 1, wherein the indicia are numbers corresponding to the distance between the indicia and the distal end of the device. 9-13. (canceled) 